US8118861B2 - Bifurcation stent and balloon assemblies - Google Patents
Bifurcation stent and balloon assemblies Download PDFInfo
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- US8118861B2 US8118861B2 US11/692,735 US69273507A US8118861B2 US 8118861 B2 US8118861 B2 US 8118861B2 US 69273507 A US69273507 A US 69273507A US 8118861 B2 US8118861 B2 US 8118861B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/856—Single tubular stent with a side portal passage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Definitions
- this invention relates to implantable medical devices, their manufacture, and methods of use and more particularly to intravascular stents that include a plurality of cavities formed on one or more surfaces of the stent and are coated with drugs
- Stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and similar implantable medical devices, collectively referred to hereinafter as stents, are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously.
- Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, fallopian tubes, coronary vessels, secondary vessels, etc.
- Stents may be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and balloon expandable (hybrid expandable). Stents may be implanted to prevent restenosis following angioplasty in the vascular system.
- a bifurcation site is an area of the vasculature or other portion of the body where a first (or parent) vessel is bifurcated into two or more branch vessels.
- the lesion(s) can affect only one of the vessels (i.e., either of the branch vessels or the parent vessel) two of the vessels, or all three vessels.
- the stent includes a tapered middle portion with a side branch assembly for positioning within the deviating branch of a body vessel.
- the portion of the stent within the first body vessel and the portion within the main branch vessel have largely different sized diameters.
- the middle region tapers steeply to bridge this diameter differential.
- the tapered middle region also angles the side branch assembly which can easily be extended at an angle to the main body of the stent.
- At least one embodiment of the invention is directed to a bifurcated stent having a distal region distal to the side opening and having a diameter, a proximal region proximal to the side opening and having a diameter, and a medial region between the distal and proximal regions.
- the stent also has a second body comprising at least one projecting member.
- the distal region diameter and proximal region diameter have different sizes and the medial region tapers from the distal region diameter size to the proximal region diameter size.
- the difference in the diameter sizes ranges from 18% to 35% inclusively.
- the at least one projecting member extends obliquely from the first body and defines a second lumen therethrough, and the second lumen is in fluid communication with the first lumen.
- a therapeutic agent coating can be positioned on at least one connector, stent member, projecting member, the distal region, the proximal region, the medial region, the first stent body, the second stent body, and any combination thereof.
- At least one embodiment of the invention is directed to a bifurcated stent in which the medial region comprises a plurality of interconnected expansion columns, at least two of the interconnected expansion columns having different maximum expansion capacities.
- the plurality can be four columns.
- a portion of the medial region extends along a sloped path between the proximal and distal regions and a portion of the medial region extending along a non-sloped linear path.
- the proximal and distal regions can also be tapered.
- At least one embodiment is directed to a bifurcated stent in which the opening plane and a portion of the first stent body in the proximal region intersect at less than 145 degrees and/or the opening plane and a portion of the first stent body in the distal region intersect at greater than 145 degrees.
- a portion of the distal region and at least a portion of the proximal region have a common axis.
- At least one embodiment of the invention is directed to a bifurcated stent having at least one expandable frame which at least partially defines the perimeter of the side opening. At least one of the at least one projecting members is engaged to the expandable frame.
- the expandable frame In the unexpanded state the expandable frame has an at least partially looped structure with one or more curved regions. The curved regions at least partially extends within the opening plane to define the side opening perimeter. In the expanded state the curved regions at least partially straighten increasing the overall circumference of the side opening area.
- This expandable frame can also increases the overall area of the opening plane along an axis generally co-linear to an axis extending from the most distal portion of the proximal region, through the opening plane, to the most proximal portion of the distal region.
- FIG. 1 is a lateral view of an expanded bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 2 is a lateral view of the medial region of a bifurcated stent.
- FIG. 3A is a lateral cross sectional image of a symmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 3B is a lateral cross sectional image of an asymmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 4A is a lateral cross sectional image of a gradually tapering symmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 4B is a lateral cross sectional image of a gradually tapering asymmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 5A is a lateral cross sectional image of a stepped tapering symmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 5B is a lateral cross sectional image of a stepped tapering asymmetrical bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 6 is a PRIOR ART bifurcated stent.
- FIG. 7 is an overhead view of the side branch assembly of a bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 8 is a cross sectional view of the side branch assembly of a bifurcated stent with a larger diameter at the portion within the parent vessel and a smaller diameter at the portion within the main branch vessel.
- FIG. 9 is representational view of the side branch assembly of an unexpanded bifurcated stent with an expandable frame array.
- FIG. 10 is representational view of the side branch assembly of an expanded bifurcated stent with an expandable frame array.
- an expanded bifurcated stent ( 1 ).
- the stent When deployed, the stent is positioned at and extends along a bifurcation site from a first or parent vessel ( 3 ) into at least two branch vessels, one being a main branch vessel ( 4 ) and one being a deviating branch vessel ( 2 ).
- the main branch vessel ( 4 ) generally extends along the same first longitudinal axis ( 16 ) as the parent vessel ( 3 ).
- the deviating branch vessel ( 2 ) generally extends along a second longitudinal axis ( 36 ).
- main branch vessel extends in a direction proximal from the bifurcation site and in which the parent vessel extends in a direction distal from the bifurcation site are contemplated by this invention; for the sake of clarity, in this application the definition of the term “parent vessel” is that branch extending in a proximal direction from the bifurcation site and the definition of the term “main branch vessel” is that branch extending in a distal direction from the bifurcation site.
- the inter-axis angle ( 90 ) formed at the intersection of the first longitudinal axis ( 16 ) and the second longitudinal axis ( 36 ) defines an oblique angle.
- oblique is an angle of greater than zero degrees, such as an angle of between about 1 and about 180 degrees and explicitly includes angles of 90 degrees and of about 90 degrees.
- the percentage difference between the diameter of the parent vessel and the diameter of the main branch vessel is a very large and is caused by a steep tapering in the walls of the main branch vessel. In the context of this application this large tapering in body vessels is referred to as rapid percent change vessels or RPs.
- the tapering in RPs helps the circulatory system maintain constant fluidic barometric pressure.
- RP body vessels examples include but are not limited to the left main coronary artery, the left anterior descending (LAD) artery, and the Circumflex artery.
- LAD left anterior descending
- the present invention while generally suited to use at a wide variety of bifurcation sites in arteries, veins, and other body lumens, in some embodiments, are particularly suited for within in RP body vessels.
- the bifurcated stent ( 1 ) is a hollow structure positionable adjacent to the body vessel wall.
- the stent ( 1 ) is typically placed on a catheter shaft and is positioned within a body vessel at the bifurcation site.
- the stent ( 1 ) comprises a first stent body ( 10 ), a side branch or ostial opening ( 18 ) along its surface, and a second stent body.
- the second stent body comprises a side branch assembly ( 30 ) adjacent to and covering at least a portion of the side branch opening ( 18 ).
- the inner surface of the first stent body ( 10 ) faces and defines a first fluid lumen ( 14 ).
- the surface of the first stent body ( 10 ) defines a first circumferential wall ( 12 ).
- the stent as a whole defines a singular tubular wall which can be substantially cylindrical or which may have regions with differing diameters or asymmetries around its longitudinal axis.
- the stent In the expanded state as shown in FIG. 1 , the stent is positioned within a bifurcation site and the first stent body ( 10 ) extends from a position within the parent vessel ( 3 ) to a position within the main branch vessel ( 4 ).
- the second stent body comprises the expanded side branch assembly ( 30 ) which extends into the deviating branch vessel ( 2 ) and defines the second fluid lumen ( 34 ).
- the first stent body ( 10 ) generally extends along the first longitudinal axis ( 16 ) of the parent vessel ( 3 ) and the second stent body ( 30 ) generally extends along the second longitudinal axis ( 36 ) of the branch vessel ( 2 ).
- a generally tubular portion of the first stent body ( 10 ) located at a position distal to the side branch assembly ( 30 ) defines the distal region ( 13 ).
- a generally tubular portion of the first stent body ( 10 ) located at a position proximal to the side branch assembly ( 30 ) defines the proximal region ( 15 ).
- a medial region ( 27 ) defines the portion of the first stent body ( 10 ) between the distal and proximal regions.
- the first and second bodies' periphery are joined at the ostium ( 38 ).
- the first and second bodies can be joined around the ostium ( 38 ) by connectors or by any other means known in the art.
- a mounting ring or expandable frame can encircle the side opening providing a defined interface between the first and second bodies.
- both the first and second stent bodies are formed from a single solid tube by known techniques such as laser cutting, chemical etching or the like.
- the side branch assembly ( 30 ) of the second body comprises two or more projecting members ( 32 ) which extend away from the first circumferential wall ( 12 ). These extended projecting members ( 32 ) define the second fluid lumen ( 34 ). The second fluid lumen is in fluid communication with the first lumen ( 14 ).
- the projecting member ( 32 ) is a petal.
- the definition of the term “petal” is one or more projecting members ( 32 ) capable of twisting, bending, pivoting or otherwise opening to define a second fluid lumen ( 34 ) by opening away from the circumferential layer ( 12 ) of the first stent body ( 10 ).
- the petals can be arranged in an iris configuration when the stent ( 1 ) is unexpanded.
- iris is one or more petals generally lying along the first circumferential wall ( 12 ) of the stent ( 1 ) in the unexpanded configuration and covering at least a portion of the side branch opening ( 18 ).
- the petals bend outward around the ostium ( 38 ) in a crown configuration to form the second fluid lumen ( 34 ).
- the transition from iris to crown configurations may be accomplished by balloon expansion, self-expansion or a combination of such mechanisms.
- the design of the medial region ( 27 ) accommodates the severe and rapid diameter percentage decrease between the diameter of the parent vessel ( 3 ) and the main branch vessel ( 4 ) found in RP body vessels.
- the distal and proximal regions each have differing diameters sized to match the respective size of the parent vessel or main branch that they are positioned within.
- the proximal region ( 15 ) has a greater expansion capability than the distal region ( 13 ). This may be accomplished by using different materials between the stent regions or by use of different stent design features such as strut dimensions differences in undulation frequency and/or amplitude, changes in cell geometry and the like, or combinations of such differences.
- the difference in diameter between the proximal and distal regions of the stent is bridged by the medial region ( 27 ) at least one embodiment of which is shown in FIG. 2 which includes several undulating expansion columns ( 28 ′, 28 ′′, 28 ′′′, and 28 ′′′′), each with progressively differing expansion properties.
- L is the continuous length of an expansion column's undulations and D is the average target vessel diameter or nominal expansion diameter of a particular stent cross section.
- Medial columns conforming to this formula allow the medial column to maintain its scaffolding properties, volume for drug coatings, and maintain appropriate SAR (surface to artery ratio used for appropriate drug dosages) while allowing for the stepped decrease or gradual taper of the stent over the bifurcation.
- the formula is applicable to expansion columns having undulations with common amplitudes.
- the L values for medial columns may be 4 mm, 3.75 mm, 3.5 mm, and 3 mm, respectively.
- the diameter difference between the most distal and most proximal column is between 18% and 35%.
- the most distal of the medial columns ( 28 ′′′′) is attached to the distal region ( 13 ) and has the same diameter as the distal region ( 13 ).
- the most proximal of the medial columns ( 28 ′) is attached to the proximal region ( 15 ) and has the same diameter as the proximal region ( 15 ).
- the intermediate medial expansion columns (which in FIG. 2 is represented by 28 ′′, 28 ′′′, but there can also be more, fewer, or none at all) provide scaffolding appropriate to particular cross sections of the rapid taper of the RP vessel or other body vessel.
- the medial region matches an RP body vessel which decreases from a diameter of 4 mm to a diameter of 2.5 mm over a distance of approximately 6 mm resulting in a slope of 0.25.
- the diameter change is from 4 mm to 3 mm over 8 mm of distance resulting in a slope of 0.125.
- Embodiments of this invention contemplate but are not limited to medial regions having a length of between 10 mm and 3 mm and which have a decrease in diameter from 5 mm to 2 mm.
- FIG. 2 illustrates a stent in which the outer surface of each of the three regions is at least partially defined by expansion columns ( 7 ) which comprise struts ( 5 ) connected to immediately adjacent struts ( 5 ′) by bent regions ( 6 ) on each end of the struts ( 5 ) and in which the expansion columns ( 7 ) are connected to adjacent expansion columns ( 7 ′) by connectors ( 37 )
- expansion columns ( 7 ) are connected to adjacent expansion columns ( 7 ′) by connectors ( 37 )
- FIG. 5 illustrates at least one embodiment in which there are four medial expansion columns, embodiments with two or more medial expansion columns are within the scope of this invention.
- the taper can be bridged by members other than medial expansion columns such as by ringed stent sections with different diameters.
- FIGS. 3A , 3 B, 4 A, 4 B, 5 A and 5 B there are at least three stent configurations utilized by a bifurcated stent for an RP body vessel.
- Each of these configurations has an asymmetric alternative ( FIGS. 3A , 4 A, and 5 A) and a symmetric alternative ( FIGS. 3B , 4 B, and 5 B).
- the trans-ostial portion ( 49 ) of the stent ( 1 ) (the portion of the medial region ( 27 ) on the opposite side of the longitudinal axis ( 16 ) from the ostium ( 38 )) is not a substantial coordinate reflection of the ostium ( 38 ) relative to the longitudinal axis ( 16 ).
- the advantage of an asymmetric alternative is that the trans-ostial portion ( 49 ) need not be expanded in an oblique direction which eases expansion, reduces the possibility of poor deployment, and reduces the possibility of barotraumas.
- At least one embodiment of the invention is directed to an RP tapered balloon catheter which when expanded, matches the geometric constraints of an RP body vessel and facilitates the delivery and deployment of the stent within an RP body vessel.
- the method of using an RP tapered balloon catheter with a RP tapered diameter stent is within the scope of the present invention.
- an RP tapered balloon curved lengthwise to match the RP tapered diameter stent is also within the scope of the present invention. Shapes including but not limited to those disclosed in FIGS. 3A , 3 B, 4 A, 4 B, 5 A and 5 B are also formed in this manner.
- using an RP tapered balloon to at least partially expand a non-RP tapered stent will also result in an RP tapered expanded stent.
- a non-tapered stent has no change in material to compensate for the change in its surface area
- such an expanded stent is RP tapered as a result of incomplete expansion.
- material fraction is the proportion of the surface of the expanded stent covered by the stent material (such as metal). Shapes including but not limited to those disclosed in FIGS. 3A , 3 B, 4 A, 4 B, 5 A and 5 B are also formed in this manner.
- FIGS. 3A and 3B each illustrate a lateral stent cross section profile in which the proximal and distal sections each have a constant diameter and a stepped medial region ( 27 ) bridges between them.
- This design addresses the rapid taper that can occur in RP vessels where the proximal and distal regions themselves are non-tapered.
- FIGS. 4A and 4B illustrate lateral stent cross section profiles in which there is a gradual taper extending completely from the proximal region through the medial region ( 27 ) to the distal region. This design is particularly suited for body vessels in which the proximal and distal regions themselves are tapered and do not have a large change in diameter between the parent vessel and the main branch.
- FIGS. 5A and 5B illustrate profiles that accommodate tapers present in the parent vessel and the main branch as well as being suited for a rapid decrease in diameter between the parent vessel and the main branch.
- tapered stent of FIG. 1 accommodates a rapid decrease in diameter between the parent vessel and the main branch.
- the sloped medial region ( 27 ) in the stent of FIG. 1 orients the side branch assembly ( 30 ) along an ostial angle ( 40 ) and within a branching plane ( 43 ) which allows the projecting members or petals ( 32 ) to extend substantially along the second longitudinal axis ( 36 ). That portion of the side opening ( 18 ) that lies along the branching plane ( 43 ) is the opening plane.
- the ostial angle ( 40 ) that the branching plane ( 43 ) forms with the first longitudinal axis ( 16 ) greatly facilitates the crowning of the side branch assembly ( 40 ).
- the fact that the entire ostial region is angled along a common branching plane ( 43 ) reduces the physical requirements of the projecting members or petal members ( 32 ) of the side branch assembly ( 30 ) to define a lumen at the same oblique angle.
- the stent of FIG. 1 also provides more side stent coverage than the PRIOR ART stent of FIG. 6 .
- a plurality of ostial engagement points ( 97 ) at the point of engagement between the extended side branch assembly ( 30 ) and the first stent body ( 10 ) encircle the ostium ( 38 ).
- one ostial engagement point ( 97 ) is a most acute side angle or acute carina ( 91 )
- one ostial engagement point ( 97 ) will be at a most obtuse side angle or obtuse carina ( 92 )
- the remainder of ostial engagement points ( 97 ) will be at one or more intermediate angles of increasing acuteness relative to their proximity to the most acute carina ( 91 ).
- the stent of FIG. 1 has projecting members ( 33 ) of equal length.
- the significance of these equally long projecting members ( 33 ) can better be understood by their comparison with the PRIOR ART stent of FIG. 6 .
- the most acute ostial engagement point ( 91 ) must be closer to the second fluid lumen terminus ( 17 ) than the other ostial engagement points ( 97 ) are.
- the most obtuse ostial engagement point ( 92 ) must be farther from the terminus than the other ostial engagement points ( 97 ). This is because in the PRIOR ART stent design of FIG. 6 , either the various projecting members ( 32 ) must have differing lengths or a terminus ( 17 ) with a non-perpendicular angle and with a non-uniform angle to the second longitudinal axis ( 36 ) will result.
- the bifurcated stent of FIG. 1 is particularly suited to provide a terminus ( 17 ) that is generally uniformly at a right angle to the second longitudinal axis ( 36 ).
- FIG. 1 shows that although the projecting members ( 33 ) can all have a common uniform length regardless of the inter-axis angle ( 90 ) they still form a terminus ( 17 ) with a generally uniform circumference.
- the projecting members ( 32 ) all have a common uniform length regardless of the inter-axis angle ( 90 ) and form a terminus ( 17 ) with a generally perpendicular circumference relative to the second longitudinal axis ( 36 ).
- each of the projecting members ( 33 ) are equally wide. In at least one embodiment, each of the projecting members ( 33 ) are equally thick.
- the stent ( 1 ) can be constructed according to a number of possible designs.
- the tubular structure of the distal and proximal regions of the stent ( 1 ) includes a plurality of interconnected expansion struts ( 5 ) which form expansion columns ( 7 ).
- the struts of various expansion columns ( 7 ) can be interconnected by connector struts ( 37 ).
- the open areas bordered by the various expansion columns ( 7 ) and connectors ( 37 ) define a plurality of cells ( 11 ).
- the first stent body ( 10 ) has at least one diameter having a first magnitude which permits intraluminal delivery of the tubular structure into the body vessel passageway, and is expanded and/or deformed to achieve upon the application of a radially, outwardly extending force to form diameters which substantially match the contours of an RP body vessel.
- the stent as a whole in the unexpanded state has a generally uniform diameter and in the expanded state the proximal distal and medial regions assume their different expanded diameters ( 8 ).
- the side opening and the second lumen can be any number of shapes including but not limited to rectangular, square, circular, elliptical, or combination thereof.
- the cells ( 11 ) are smaller than the side branch opening ( 18 ).
- the base of the side branch assembly ( 30 ) is an expandable frame ( 47 ).
- expandable frames are disclosed in the commonly owned co-pending application 60/859,420 having an attorney docket number of S63.2-13226-US01 which has a title of “Bifurcation Stent Design with Over Expansion Capability” which is hereby incorporated by reference in its entirety.
- the expandable frame ( 47 ) in the unexpanded state, has a generally looped structure about at least a portion of the side opening with one or more curved regions or additional nested peaks ( 39 ) lying along the first circumferential wall ( 12 ).
- the nested peaks depicted in FIG. 7 comprise a first ascending segment ( 39 ′), a second descending segment ( 39 ′′), a third ascending segment ( 39 ′′′), a fourth descending segment ( 39 ′′′′), a fifth ascending segment ( 39 ′′′′′), and a sixth descending segment ( 39 ′′′′′′). While FIG. 7 illustrates a nested peak configuration having six segments, embodiments with more or fewer segments are contemplated by the invention.
- the nested peaks ( 39 ) when in the unexpanded state reduce the overall area of the circumferential wall ( 12 ) that the base of the side branch assembly ( 30 ) occupies when the stent is in the unexpanded configuration.
- the expandable frame ( 47 ) is expanded as shown in FIG. 8 , the additional nested peaks ( 39 ) expand along the branching plane ( 43 ) in a direction co-linear to the opening plane and with the remainder of the base of the side branch array ( 30 ).
- co-linear defines a relationship of elements where all of the elements are in a common linear order relative to a single axis. This expansion increases the area of the base the side branch assembly ( 30 ) crowns away from.
- the expandable frame ( 47 ) allows for greater amount of scaffolding support for the side branch assembly ( 30 ) without impinging on the stent's overall performance or its ability to be crimped into a size appropriate for implantation.
- Petals or other projecting members can be engaged to the nested peak ( 39 ) allowing the second stent body to define a second fluid lumen with a greater volume.
- the expanded nested peak of FIG. 8 is completely extended to form a substantially rounded side branch assembly base.
- the nested peaks only partially expand to result in an expanded side branch assembly base which still retains some peaked structures.
- two or more nested peaks are present on the side branch assembly.
- the expandable frame ( 47 ) facilitates the increase in length that the side branch assembly spans when the stent is expanded.
- FIGS. 9 and 10 show that the base of the side branch assembly ( 30 ) when unexpanded as shown in FIG. 9 , has a longitudinal length ( 71 ) running parallel to the longitudinal axis ( 16 ) which is equal to the sloped length ( 51 ) (the length measured according to the slope of the side branch assembly base ( 30 )).
- FIG. 10 however illustrates that the diagonal slope length ( 51 ) becomes larger than the longitudinal length ( 71 ) when the stent is expanded.
- FIG. 9 shows that the ascending and descending segments ( 39 ′, 39 ′′, 39 ′′′) occupy similar or overlapping longitudinal positions when unexpanded. It should be understood that FIG. 9 is a schematic drawing and the segments are positioned only to demonstrate their longitudinal offsets, they are not in fact layered on top of each other but are alongside each other as illustrated in FIG. 8 .
- FIG. 10 illustrates that when expanded, at least some of the segments ( 39 ′, 39 ′′, and 39 ′′′) have longitudinally offset positions from each other which increases the length of the side branch assembly base and help it to span the increased distance.
- FIG. 2 when expanded, the bent region ( 6 ) of the endmost expansion column in the medial region extends substantially past and out from under the base of the side branch assembly relative to the longitudinal axis.
- the expanded descending segments ( 39 ) extend the base farther which in turn causes the strut's bent regions to be positioned below or at least less distant from the extending segments ( 39 ).
- Such positioning avoids crowding portions of the medial region against the distal or proximal regions and provides extra space for fitting longer struts, longer bent regions, or any other stent member.
- the stent, its delivery system, or other portion of an assembly may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc.
- imaging modalities such as X-Ray, MRI, ultrasound, etc.
- at least a portion of the stent and/or adjacent assembly is at least partially radiopaque.
- At least a portion of the stent is configured to include one or more mechanisms for the delivery of a therapeutic agent.
- the agent will be in the form of a coating or other layer (or layers) of material placed on a surface region of the stent, which is adapted to be released at the site of the stent's implantation or areas adjacent thereto.
- the therapeutic agent can be at least one or various types of therapeutic agents including but not limited to: at least one restenosis inhibiting agent that comprises drug, polymer and bio-engineered materials or any combination thereof.
- the coating can be a therapeutic agent such as at least one drug, or at least one other pharmaceutical product such as non-genetic agents, genetic agents, cellular material, etc.
- suitable non-genetic therapeutic agents include but are not limited to: at least one anti-thrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc.
- an agent includes a genetic therapeutic agent, such a genetic agent may include but is not limited to: DNA, RNA and their respective derivatives and/or components; hedgehog proteins, etc.
- the cellular material may include but is not limited to: cells of human origin and/or non-human origin as well as their respective components and/or derivatives thereof.
- the therapeutic agent includes a polymer agent
- the polymer agent may be a polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and/or any other suitable substrate.
- SIBS polystyrene-polyisobutylene-polystyrene triblock copolymer
- silicone rubber any other suitable substrate.
- any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims).
- each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims.
- the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claims below.
Abstract
Description
L Proxiaml /D Proximal =L Distal /D Distal
Claims (15)
Priority Applications (3)
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US11/692,735 US8118861B2 (en) | 2007-03-28 | 2007-03-28 | Bifurcation stent and balloon assemblies |
PCT/US2008/002330 WO2008118267A1 (en) | 2007-03-28 | 2008-02-22 | Bifurcation stent and balloon assemblies |
EP08725920A EP2129342A1 (en) | 2007-03-28 | 2008-02-22 | Bifurcation stent and balloon assemblies |
Applications Claiming Priority (1)
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US11/692,735 US8118861B2 (en) | 2007-03-28 | 2007-03-28 | Bifurcation stent and balloon assemblies |
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US20080243232A1 US20080243232A1 (en) | 2008-10-02 |
US8118861B2 true US8118861B2 (en) | 2012-02-21 |
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US11/692,735 Expired - Fee Related US8118861B2 (en) | 2007-03-28 | 2007-03-28 | Bifurcation stent and balloon assemblies |
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US (1) | US8118861B2 (en) |
EP (1) | EP2129342A1 (en) |
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